Lawmakers at both the state and federal levels are pushing measures to allow people with terminal illnesses access to promising but still experimental drugs and treatments. Some are also attempting to force the federal Food and Drug Administration to speed up its approval process. Heartland Health Monitor’s Andy Marso recently paid a visit to a Kansan suffering from Lou Gehrig’s disease who believes she could be helped by a drug that’s not yet on the market.
Kelli Johnsen has had ALS for seven years now, and it’s making everyday life increasingly hard for her. She used to make the trip from her home in Emporia to see her doctor in Kansas City every three months, but now goes just every six months.
State Rep. Don Hill, a moderate Republican from Emporia, is one of several lawmakers who has co-sponsored a Right to Try bill. It would allow terminally ill Kansans like Johnsen to access drugs that have passed only the earliest stages of FDA testing.
During a recent visit to her home, Hill briefed Johnsen on his strategy for moving the bill through the legislative process.
“I’ve met a couple of times – I saw him again yesterday – with Dan Hawkins, who is the chair of the Health Committee in the House," he said.
Johnsen spends a lot of her time on the Internet searching for drugs that could possibly help slow the disease that’s taking her life. She’s found one--but the drug is still being tested. And the company that makes it says it could be three years before it clears the FDA and reaches the market.
Johnsen can't wait that long.
But her wait may not be shortened even if Hill’s bill passes in the 2016 session. There’s no guarantee she will get to try Genervon’s drug. More than 20 states, including Missouri, have right to try laws on the books. But even in those states drug companies remain reluctant to distribute their products prior to FDA approval.
Federal legislation being pushed by Kansas Congressman Kevin Yoder might be more helpful to people like Johnson in the future. It would double federal funding for medical research and speed the FDA approval process.
Yoder, a Republican who represents the Kansas City area, is a fiscal conservative. But during a floor speech this summer he said medical research and the drug approval process are not places to pinch pennies.
“We know each year 600,000 people will die of cancer. We know each year in the United States 700,000 people will die of Alzheimer’s," he said. "These are real people. Real families that are in anguish over these and many other diseases.”
But not everyone thinks the FDA should be approving more medications more quickly.
Kansas City attorney John Parisi represents people who say they’ve been harmed by prescription drugs or medical devices. More than 10,000 lawsuits have been filed against drugs like Yasmin and Vioxx. Parisi says that shows that the FDA is already struggling to keep dangerous products off the market.
“Because the consequences of putting a drug on the market too soon, as you can see by, again, this list of drugs where all these people have suffered unintended or undisclosed side effects as serious as, you know, loss of life," Parisi says. "While you want to get the drug to the market you want to make sure the drug is safe and effective.”
Johnsen is well aware of the risks. But she says it should still be her choice to make.
“I would like to see a little more flexibility and (that) they be more willing to listen to patients and understand that we are able to make an informed choice when we have all the information," she says.
This debate requires lawmakers to strike a balance between protecting the public and preserving the rights of individuals. And until they figure out how to do that, Johnsen, and others like her, will have to wait.